TherapyMatch-D: A randomized controlled trial of psychological treatment selection for depressio

Not Applicable

• Conditions: Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN21721966
• Lead Sponsor: Rotherham Doncaster and South Humber NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-22
• Last Update Posted: 19 August 2024
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

Therapists/Counsellors:
1. Be employed by a participating IAPT service on a permanent contract, or be employed as temporary staff with a contract that is at least as long as the expected timescale for the project (1 year)
2. Hold a UK-recognized qualification and be approved by IAPT to carry out routine assessments in an IAPT service
3. Attended a group/individual training on how to utilize the computer programme TherapyMatch-D

Patients
1. Adults (18 years of age or older).
2. With depression (defined as scoring at least 10 on the PHQ-9), including those with co-morbid anxiety and those taking antidepressant medication (we will monitor and examine potential confounding effects of comorbidity and medication).
3. Seeking mental health care in IAPT services at Step 3 (normally via self-referral, GP referral or stepped up from Step 2 low-intensity IAPT treatment).
4. Deemed eligible for high-intensity treatment in IAPT by assessing therapists (often patients who do not improve at the earlier steps of care), regardless of any prior mental health treatment from IAPT or elsewhere (we will monitor and examine potential confounding effects of prior treatment and baseline severity).
5. Able to take part in the initial assessment in English without the need for interpreters or substantial communication adaptations.

Note. The researchers will gather information from all consenting participants (216 per arm). However, only those will a differential treatment response as identified by the algorithm in the TherapyMatch-D computer programme, which we estimate would be approximately 30% of the 216 participants (64 participants per arm), will be included in the primary outcome analysis.

In the sub-study, purposive sampling will be used to recruit 4 patients from each arm of the trial (2 per intervention) and 4 clinicians from each arm of the trial. This will result in a planned sample size of 16 participants.

Exclusion Criteria

Therapists/Counsellors:
1. Employment contract with IAPT service is shorter than the expected timescale for the study (1 year)
2. Currently in training (since they are not yet fully qualified to carry out routine assessments) without holding a UK-recognized qualification
3. Failure to attend a group/individual training on how to utilize the digital tool TherapyMatch-D

Patients:
1. Individuals below 18 years old
2. Lack of ability to provide informed consent to participate (as determined by the assessing therapist as part of a routine assessment)
3. Patients who do not provide informed consent to participate
4. Patients who are assessed as ineligible for treatment in IAPT (e.g., those who are signposted to other services, or lacking capacity to consent to an assessment). Specific criteria for IAPT exclusion are detailed elsewhere. Common examples include having other severe mental health disorders, highly acute suicide risk, and comorbid substance use disorder that interferes with the person’s ability to engage in therapy
5. Unable to take part in the initial assessment due to language or communication barriers, or requiring substantial adaptations or interpreters

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliable and Clinically Significant Improvement (RCSI) in depression, measured by the Patient Health Questionnaire-9 questionnaire (PHQ-9) at the end of the treatment period (last session of therapy, either CBT or PCE-CfD)